Pyoderma Gangrenosum
Conditions
Keywords
Pyoderma Gangrenosum, Ulcer, Efficacy, Safety, Adalimumab, Humira®, Japan
Brief summary
This study is designed to investigate the efficacy, safety and pharmacokinetics of adalimumab in subjects in Japan with active ulcer(s) due to Pyoderma Gangrenosum (PG).
Interventions
DRUGadalimumab
Study drug will be administered subcutaneously.
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be able and willing to provide written informed consent. If the participant is \< 20 years old, a parent or legal guardian must be willing to give written informed consent * Participants must have a diagnosis of ulcerative (classic) PG made by the Investigator * Participants must have demonstrated an inadequate response to conventional PG therapy or in the opinion of the Investigator they are not a suitable candidate for conventional PG treatment.
Exclusion criteria
* Participants with pustular, bullous/atypical, or vegetative variants of PG * Participants with clinical evidence of ulceration that is non-PG related, vasculitis, thrombosisprone conditions, or monoclonal gammopathy * Participants with a histopathological finding that is consistent with a diagnosis other than PG * Participants receiving a therapeutic dose of prednisolone * Participants with prior exposure to adalimumab or previous participation in an adalimumab clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who have achieved target Pyoderma Gangrenosum Area Reduction (PGAR) | Week 26 | The participants will be assessed whether they meet target PGAR at Week 26 based on PGAR score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean time to occurrence of new PG ulcers | Up to Week 26 | A new PG ulcer is defined as not present at Baseline and not caused by the epithelial bridging of an existing ulcer at Baseline. The time after Baseline when the new lesion was observed will be recorded. |
| Change from Baseline in total number of active ulcers | Week 26 | The number of all active PG ulcers will be counted at the specified visits. |
| Change from Baseline in Dermatology Life Quality Index (DLQI) | Week 6 and Week 26 | The DLQI will be used to assess the symptoms and the impact of skin problems on quality of life. |
| Changes from Baseline in total ulcer area | Week 6 and Week 26 | The change in total ulcer area is assessed. |
| Proportion of participants with inflammation reduction as assessed on an Investigator Inflammation Assessment (IIA) Score | Up to Week 26 | The Investigator assesses the inflammation status of the target ulcer at the specified visits according to the scales. |
| Mean time to occurrence of a new PG ulcer(s) | Up to Week 52 | Mean time to occurrence of a new PG ulcer(s) is assessed. |
| Mean time to healing of target ulcer | Up to Week 52 | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. |
| Proportion of participants achieving healing per PGAR for the target ulcer | Week 52 | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. |
| Proportion of participants who have achieved target PGAR | Up to Week 26 | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. |
| Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1 | Week 6 and Week 26 | The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits. |
| Proportion of participants achieving PGA 0 | Week 6 and Week 26 | The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits. |
| Change from Baseline in Pain as measured by Numerical Rating Scale (NRS) | Week 6 and Week 26 | The Numerical Rating Scale of Pain sheet will be filled out in the office by participants at the designated visits. |
| Changes from baseline in the proportion of participants taking analgesics | Week 6 and Week 26 | Proportion of participants taking analgesics is assessed. |
| Velocities of healing | Up to Week 26 | This is assessed from baseline. |
| Proportion of participants achieving ulcer healing as assessed by PGAR | Week 6 | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. |
| Proportion of participants achieving PGA 0 of all PG ulcers | Week 52 | The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits. |
| Mean time to relapse of the target PG ulcer | Up to Week 26 | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. |
| Mean time to healing as defined by PGAR | Up to Week 26 | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. |
| Percentage change in target Pyoderma Gangrenosum (PG) ulcer area | Up to Week 26 | The percentage change in target PG ulcer area is assessed. |
Countries
Japan
Outcome results
None listed